女性在心血管药物试验中的充分入组以及进行性别特异性评估和报告的必要性。

Adequate enrollment of women in cardiovascular drug trials and the need for sex-specific assessment and reporting.

作者信息

Carland Corinne, Hansra Barinder, Parsons Cody, Lyubarova Radmila, Khandelwal Abha

机构信息

Department of Medicine, University of Pennsylvania, United States of America.

Division of Cardiology and Department of Critical Care Medicine, UPMC, United States of America.

出版信息

Am Heart J Plus. 2022 Jun 23;17:100155. doi: 10.1016/j.ahjo.2022.100155. eCollection 2022 May.

Abstract

Cardiovascular disease (CVD) is the leading cause of death for women in the United States and globally. There is an abundance of evidence-based trials evaluating the efficacy of drug therapies to reduce morbidity and mortality in CVD. Additionally, there are well-established influences of sex, through a variety of mechanisms, on pharmacologic treatments in CVD. Despite this, the majority of drug trials are not powered to evaluate sex-specific outcomes, and much of the data that exists is gathered post hoc and through meta-analysis. The FDA established a committee in 1993 to increase the enrollment of women in clinical trials to improve this situation. Several authors, reviewing committees, and professional societies have highlighted the importance of sex-specific analysis and reporting. Despite these statements, there has not been a major improvement in representation or reporting. There are ongoing efforts to assess trial design, female representation on steering committees, and clinical trial processes to improve the representation of women. This review will describe the pharmacologic basis for the need for sex-specific assessment of cardiovascular drug therapies. It will also review the sex-specific reporting of landmark drug trials in hypertension, coronary artery disease (CAD), hyperlipidemia, and heart failure (HF). In reporting enrollment of women, several therapeutic areas like antihypertensives and newer anticoagulation trials fare better than therapeutics for HF and acute coronary syndromes. Further, drug trials and cardiometabolic or lifestyle intervention trials had a higher percentage of female participants than the device or procedural trials.

摘要

心血管疾病(CVD)是美国和全球女性死亡的主要原因。有大量基于证据的试验评估药物疗法在降低CVD发病率和死亡率方面的疗效。此外,性别通过多种机制对CVD的药物治疗有既定的影响。尽管如此,大多数药物试验没有足够的能力来评估性别特异性结果,现有的许多数据是事后收集并通过荟萃分析获得的。美国食品药品监督管理局(FDA)在1993年成立了一个委员会,以增加女性参与临床试验的人数,改善这种情况。几位作者、评审委员会和专业协会都强调了性别特异性分析和报告的重要性。尽管有这些声明,但在代表性或报告方面并没有取得重大改善。目前正在努力评估试验设计、指导委员会中的女性代表性以及临床试验流程,以提高女性的代表性。本综述将描述对心血管药物疗法进行性别特异性评估的药理学依据。它还将回顾高血压、冠状动脉疾病(CAD)、高脂血症和心力衰竭(HF)等具有里程碑意义的药物试验的性别特异性报告。在报告女性参与人数方面,一些治疗领域,如抗高血压药物和新型抗凝试验,比HF和急性冠状动脉综合征的治疗方法表现更好。此外,药物试验以及心脏代谢或生活方式干预试验的女性参与者比例高于器械或程序试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/776e/10978324/e3268e026354/gr1.jpg

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